Health Products Regulatory Authority
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
CEVAC MASS L lyophilisate for oculonasal suspension for chicken
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (0.2 ml) contains:
Active substance:
Live, attenuated infectious bronchitis virus (IBV), Massachusetts B-48 strain
*EID50= 50 % embryo infective dose
102.8 - 104.3 EID50*
Excipients
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for oculonasal suspension.
Yellowish pellet.
4 CLINICAL PARTICULARS
4.1 Target Species
Chicken
4.2 Indications for use, specifying the target species
For the active immunisation of chickens against infectious bronchitis (Massachusetts serotype), in order to reduce
respiratory clinical signs, detrimental effect on the ciliary activity and presence of virus in the trachea.
Protection was demonstrated by challenge with the Massachusetts M41 strain.
Onset of immunity: 3 weeks following vaccination.
Duration of immunity: 6 weeks following vaccination.
4.3 Contraindications
None.
4.4 Special warnings for each target species
None.
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Date Printed 20/05/2016
CRN 7022336
page number: 1
Health Products Regulatory Authority
4.5 Special precautions for use
Special precautions for use in animals
Vaccinate healthy animals only.
Vaccinated chickens may excrete the vaccine strain for up to 28 days following vaccination.
During this time, special precautions should be taken to avoid spreading of the vaccine strain to unvaccinated chickens
and to other bird species, if any are close by.
All chickens within the same farm should be vaccinated before or when entering the premises.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Not applicable.
4.6 Adverse reactions (frequency and seriousness)
No significant clinical symptoms were detected after administration of the product. Mild tracheal rales commonly
occurred in animals 4 - 6 days after vaccination, which resolved completely in a few days. In rare cases transient
conjunctivitis can occur.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals )
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports)
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been studied during lay.
Do not use in birds in lay and within 4 weeks before the onset of the laying period.
4.8 Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal
product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be
made on a case by case basis.
4.9 Amounts to be administered and administration route
For nebulisation use.
The vaccine should be administered from one day of age, one dose / chicken.
Dilute the vaccine in distilled water, or in cold, clear water, free from disinfectants. The quantity of water should be
sufficient to allow a uniform distribution of the vaccine when spraying the chickens. The 1000 dose vaccine is
recommended to be dissolved in 200 ml water, whereas this ratio should be considered when dissolving other types of
presentation.
Vaccination is recommended in the form of coarse spray assuring a droplet size of 100 - 200 µm. It is preferable that
the chickens are sitting together in dim light or closely confined during spraying. The ventilation should be switched
off during and after vaccination in order to avoid turbulences. Vaccination should be performed during the coolest time
of the day.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No further reactions above the side effects mentioned under adverse reactions were observed after administering a 10fold dose of the vaccine.
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Date Printed 20/05/2016
CRN 7022336
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Health Products Regulatory Authority
4.11 Withdrawal Period(s)
Zero days.
5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: immunologicals for Aves / domestic fowl / live viral vaccines
ATCvet code: QI01AD07
To stimulate active immunity against the Massachusetts serotype of avian infectious bronchitis virus in chickens.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Lactose
Sorbitol
Gelatine
Potassium dihydrogen phosphate
Dipotassium phosphate
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after dilution according to directions: 2 hours
6.4 Special precautions for storage
Store and transport refrigerated (2 °C - 8 °C).
Protect from light.
The diluted vaccine is to be kept below 25 °C.
6.5 Nature and composition of immediate packaging
The vaccine is supplied in 3 or 10 ml type I glass vials, sealed with bromobutyl rubber stoppers and aluminium caps
with plastic (flip-off) tops.
Cardboard box with 1 vial of 1000 doses
Cardboard box with 1 vial of 2500 doses
Cardboard box with 1 vial of 5000 doses
Cardboard box with 10 vials of 1000 doses
Cardboard box with 10 vials of 2500 doses
Cardboard box with 10 vials of 5000 doses
Cardboard box with 20 vials of 1000 doses
Cardboard box with 20 vials of 2500 doses
Cardboard box with 20 vials of 5000 doses
Not all pack sizes may be marketed.
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Date Printed 20/05/2016
CRN 7022336
page number: 3
Health Products Regulatory Authority
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be
disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
CEVA-Phylaxia Veterinary Biologicals Co. Ltd
1107 Budapest
Szállás u. 5.
Hungary
8 MARKETING AUTHORISATION NUMBER(S)
VPA 10463/004/001
9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 20th May 2016
10 DATE OF REVISION OF THE TEXT
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Date Printed 20/05/2016
CRN 7022336
page number: 4